What Form of Communication Is Used to Indicate Informed Consent?

Appl Clin Inform. 2011; two(ii): 240–249.

The Role of Nonverbal and Verbal Advice in a Multimedia Informed Consent Process

Joseph M. Plasek

¹Marshfield Clinic Inquiry Foundation, Marshfield, Wise., Us

²University of Minnesota, Minneapolis, Minn., USA

David South. Pieczkiewicz

^aneMarshfield Clinic Research Foundation, Marshfield, Wise., USA

ⁱⁱUniversity of Minnesota, Minneapolis, Minn., USA

Andrea N. Mahnke

¹Marshfield Dispensary Research Foundation, Marshfield, Wise., U.s.a.

Catherine A. McCarty

¹Marshfield Dispensary Research Foundation, Marshfield, Wise., USA

Justin B. Starren

^aneMarshfield Clinic Research Foundation, Marshfield, Wise., USA

Bonnie Fifty. Westra

²University of Minnesota, Minneapolis, Minn., USA

Received 2011 Feb xvi; Accustomed 2011 May five.

Abstruse

Objective

Nonverbal and verbal advice elements raise and reinforce the consent course in the informed consent procedure and need to be transferred appropriately to multimedia formats using interaction design when re-designing the process.

Methods

Observational, question request behavior, and content analyses were used to analyze nonverbal and verbal elements of an informed consent process.

Results

A variety of gestures, interruptions, and communication styles were observed.

Conclusion

In converting a verbal conversation well-nigh a textual document to multimedia formats, all aspects of the original procedure including verbal and nonverbal variation should be ane role of an interaction community-centered blueprint approach.

Keywords: Informed consent, gestures, user-computer interface, multimedia

1. Introduction

An informed consent procedure usually contains a standard IRB approved textual document, which is typically described to a participant by a inquiry coordinator using variable verbal language and body gestures. Previous studies focused on improving the textual certificate, or changing the presentation medium [i–12], but footling research has been conducted to make up one's mind the variability inherent in the verbal consent process. Little enquiry has focused specifically on how written consent forms are integrated into a exact dialogue between a potential research participant and the person administering the consent.

Marshfield Clinic'south Personalized Medicine Inquiry Project (PMRP) conducts genetic studies in which they collect blood, and plasma samples, and requires written informed consent for participation. A recent study of PMRP participants shows that although the participants understood the overall goals of the project, many were unsure or incorrect most primal factors of the study [13]. Results of this study suggest that incorrect responses were due to a lack of comprehension, rather than a loss of memory of specific details, since the percent of correct responses was not related to the time since consenting to the PMRP project [xiii, 14].

Marshfield Clinic identified a need to improve their methods of informed consent to ensure that participants are fully informed when they consent to be in the report and that they retain that information. This report is one phase of a larger project to develop a multi-media informed consent process that is acceptable to potential research participants and improves the retention of information. The purpose of this phase of the written report was to determine the human relationship between the nonverbal and exact elements of the informed consent process for PMRP prior to determining how to transform the content and process to a multi-media format. This study fills a gap in knowledge past formally analyzing the current consent process in a novel mode using homo factors methods that include observational, question asking behaviors and content analyses. The application of this research is a proof-of-concept guide to the incorporation of both nonverbal and verbal communication elements in a multi-media informed consent application.

2. Background

The researchers' function in the informed consent process is to inform participants equally to the truthful nature, aims, and intent of the report by describing what to expect if they concord to participate, and through full disclosure of the purpose, anticipated benefits, risks, alternatives, and expected outcomes of the study; to answer any questions the participant may have; and to respect the participants consent or dissent [seven–10]. Based on previous inquiry, potential written report subjects are more likely to actually read the consent form if it is given to them to review at their leisure; thus, it follows that multimedia education materials, which are self-paced, are besides more likely to be reviewed [fifteen].

Multimedia education consists of a variety of combinations of text, sound, video, interactive questionnaires, visualizations, graphics, or even immersion into a virtual 3D environment [vii]. Agre and Rapkin measured comprehension of consent information amongst 204 participants randomized to one of four consent processes: standard, video, computer-assisted education, or booklet, and reported that comprehension was unchanged beyond all groups on the mail service test regardless of the delivery method, suggesting that the media used to present the informed consent process does not matter [1, 12].

A multimedia tool has the potential to standardize the quality of informed consent; however, previous studies take failed to create a generalized solution [7]. These studies fail to assess either the competence of the patient, the ceremoniousness of the educational level of the material, or the effectiveness of the electronic consent process [vii]. Although a estimator-based informed consent procedure adds a level of standardization, it must be tailored to the private participants' learning style as ane-size-fits-all interventions may not be universally generalize-able [xvi]. Agre and Rapkin fence that a successful consent process must, at a minimum, include both a written and a verbal component, possibly even using the technique of asking the participant to repeat what he or she understands, and the participant should interact one on one with someone knowledgeable near the written report at some point in time [i, 12]. A counterintuitive result identified in Agre and Rapkin'south study is that participant comprehension of an informed consent grade increases when participants had a higher level of formal education, or when the report protocol was very complex (i.east. the study had more than risks, side effects, or procedures to explain), requiring a simplified, longer caption [1, 12]. Yet, the transferability of exact and nonverbal communication elements to multimedia technologies is impeded past the tacit nature of these elements.

3. Methods

Data was obtained past conducting "mock" informed consent sessions with a convenience sample of six Marshfield Clinic employees and half dozen Biomedical Informatics Research Centers' usability community volunteers. Since the PRMP project is a population-based biobank that recruits from the community, including Marshfield Dispensary employees, these subjects were typical of PRMP subjects. The sample size is considered adequate for a proof-of-concept paper. The nonverbal and exact elements were captured by videotaping and digitally recording twelve mock consent sessions.

All 12 "mock" sessions were conducted by the same enquiry coordinator, who was too responsible for administering actual PRMP consents and was well acquainted with the process, with subjects as though they were enrolling in a written report. Subjects were consented to the videotaping of the written report of the consent process, and were aware that the purpose of the research was to study the consent process itself rather than to enroll them into the PMRP projection. Certified medical transcriptionists at the Marshfield Clinic professionally transcribed audio from the twelve sessions.

three.1. Analysis

The nonverbal elements of the informed consent process were analyzed using an observational assay [17], where the investigator observed the videos and documented the nonverbal behaviors of the research coordinator. 11 videos were analyzed for gesture, heart gaze, and body posture for nonverbal cues that the research coordinator used within the consent process in communication with the inquiry participant. For the observational analysis, one session was excluded due to technical issues that resulted in the loss of the video. Observational analysis was used to generate a list of gestures with classifications like to Bickmore et al. and Whishaw et al [18, 19]. Analysis of heart gaze and torso posture is used to show how the enquiry coordinator uses the written consent form equally a form of external scaffolding, where 1 places knowledge in the environment that the research coordinator relies on to aid their thoughts in order to remind the coordinator to cover elements of the consent course within their verbal explanation [20]. Gestures are also used equally perceptual-motor information scaffolding for perceptual-motor information, where their manus gestures reflect properties of the item objects and the deportment they have previously used to remember and convey the concepts in a exact consent [21]. Assay of gestures is used to depict and make inferences about the characteristics of communication to analyze style and techniques of persuasion.

The exact elements of the informed consent process were analyzed for question asking behaviors initiated by the participant that created dialogue using a content analysis [22, 23]. Question asking behavior analysis highlights the of import function of the enquiry coordinator in answering questions from the research participant and shows the usefulness of supplementary materials in a multimedia version every bit a means of tailoring to the needs of a detail participant. The question asking beliefs analysis uses frequency of questions asked by the participants as a ways to analyze the flow of information. The written consent class consists of 20 specific sections or content areas.

A content assay was used to depict trends in communication content, to analyze techniques in persuasion, and to make up one's mind the residual of personalized narrative for paraphrasing within the current exact consent procedure [23]. The content analysis is a qualitative method used to analyze the content of communication and is validated using inter-rater reliability. A content analysis was conducted on four transcripts to determine how the verbal process compliments and extends the written consent form in terms of content and style of delivery. One transcript was analyzed by a 2d coder to establish interrater reliability using Cohen'due south Kappa. In this study, the focus was on the words used by the enquiry coordinator that could be a paraphrasing of data in the consent form or a personalized narrative to connect to the individual participant'due south situation or even a joke to elicit participant response.

four. Results

The data for not-verbal observational analysis included one,903 observations that were classified, and analyzed from the 11 videotaped sessions. The types of observations that were gathered within the observational analysis include:

1.

General hand gestures refers to whatever waving of the paw, conducting, paddling, arcing, or tapping in air gestures that are not specific.
2.

Specific conversational paw gestures are actions made by the research coordinator that communicate more than a wave of the hand to the participant, which may add value to the consent process past representing a concept or by re-assuring the participant.
3.

Highlighting gestures are where the enquiry coordinator points to, traces, or taps a sentence or word.
4.

Resting gestures are where the enquiry coordinator's easily are folded or placed face down on the table or along the corners at the tiptop of the consent document, which add value to the consent procedure by removing unnecessary motion and past inviting the participant to ask questions of the research coordinator.
5.

Repositioning gestures are where the enquiry coordinator does something with the paper certificate, by either straightening the consent certificate, or turning to a new page, which are necessary to assist the participant follow along with the paper consent process.
6.

Other specific hand gestures are deportment where the enquiry coordinator, for example, is: touching their chest, counting, 'what-ever', sliding hands beyond the tabular array, simulating a needle prick in the arm vein, creates a circle, creates a crossing out or stopping gesture to cancel something out, or presents something equally 'door number 1 vs. door number ii'.
7.

Head gestures are where the enquiry coordinator is nodding or shaking their own head within the conversation and may be used to reassure the participant.
eight.

Eye gaze refers to when the research coordinator gazes downward at the written consent document, or into the participant's eyes, which is important for communicating ideas or focusing attention elsewhere.
9.

Torso posture refers to where the research coordinator leans frontwards towards the participant, or leans dorsum confronting the chair.
10.

Transition patterns are combinations of gestures that form a common pattern that occur in the transition at the beginning of a new department where the research coordinator leans forward gazing down at the page and either points to or traces the important text.

Of the one,903 observations presented in ►Figure i,77% were paw gestures (29% general hand waving, 13% specific hand waving, 20% highlighting, ten% resting, and 5% repositioning), 12% were caput gestures, 5% were body posture shifts, and 5% were middle gazes.

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For the exact analysis of the mock informed consent, there was a full of 61 questions asked by participants over the 12 sessions, respective to 14 of the 20 sections on the consent form that were analyzed using question asking behavior analysis. ►Figure 2 presents the frequency of questions organized by section of the consent form where the participant interrupted the research coordinator to enquire a question or to get further description on an idea. Content in ►Figure 2 is presented in the same society every bit the 20 sections of the consent form, excluding the last section on "statement of consent" (i.e., where the participant is asked to sign the consent form).

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Number of observations, questions, and sentences by section of the personalized medicine research project (PMRP) consent form ordered temporally

The informed consent sections with the most questions in decreasing guild were: what will happen if you agree to take part in PMRP, how will privacy and confidentiality be protected, who may have access to your report information, what are the possible risks and discomforts of the project and, volition you ever be re-contacted for additional data. The sections with no questions are: what is informed consent, what are the possible benefits of the research project to y'all, what are the costs for taking office in this project, will any commercial products be developed from PMRP, practice you lot have to have part in this projection, and the statement of consent.

Paraphrased explanations were typically followed by a personalized communication style to reduce the complexity of the message into more simplified version to improve the comprehension of the participant. The research coordinator never read the text of the consent form verbatim and only comes close to doing so when initially describing the consent form section why they were asked to take office in the research study. ►Tabular array ane shows the breakdown of the content analysis between paraphrased and personalized sentences. Inter-rater reliability was calculated on one transcript using a Cohen's Kappa with a "proficient agreement" result of 73.8%.

Table 1

Method of communication by transcript

Communication Method	Transcript A		Transcript B	Transcript C	Transcript D
	Reviewer i	Reviewer 2	Transcript B	Transcript C	Transcript D
	due north	due north	n	due north	due north
Personalization/Narrative	25	27	21	35	32
Error	1	1	ii	0	2
Joke	0	3	two	2	1
Question	5	8	eight	5	half-dozen
Subtotal: Personalized	31	39	33	42	41
Paraphrased	71	63	22	79	61
Total Sentences	102	102	55	121	102

five. Discussion

The purpose of this the study was to determine the relationship betwixt the nonverbal and exact elements of the informed consent process for PMRP prior to determining how to transform the content and process into a multi-media format. The written informed consent is reinforced through a procedure that involves both nonverbal and verbal communication. Our main finding was to identify which sections of the informed consent were complex for participants to empathize based on the frequency of questions asked. We also identified that dissimilar types of gestures, body postures, and verbal communication were used to reinforce the consent procedure.

The key finding of the observational analysis is the variability in types and frequency of gestures, torso posture, and middle gaze. The results of this study are similar to results by Bickmore et al, which showed that face-to-face consents are effective because researchers apply exact and nonverbal behaviors, such as head nods, manus gesture, center gaze cues and facial displays to communicate factual information to patients, also as to communicate empathy and immediacy to elicit participant trust [18]. A transition pattern may indicate where the research coordinator uses the paper consent as a style to jog their own memory to ensure that of import aspects of the consent are covered. The implication of these findings for the pattern of multi-media informed consent applications is that developers should ensure that the new application replaces the nonverbal communication with appropriate interaction techniques.

Data that is currently conveyed in gestures demand not be replaced with video of the same gestures. The information might be presented using textual cues, pictures, or multimedia to enhance the consent course. For instance, highlighting gestures like pointing, tapping, or tracing could exist replaced with a stylized text that is bolded or italicized, or with a bigger font size. In the same line of thought, counting gestures, which indicate a list of items, could be replaced with bullet points or numbers. Past virtue of the new presentation medium, certain types of gestures including: general hand waving, resting gestures, posture, and eye gaze would be irrelevant and thus could be discarded.

Other types of specific hand waving gestures could similarly be replaced or discarded as appropriate. Repositioning gestures are more often than not due to the confines of the paper medium where page turns are necessary to bring forward new content, and tin can probably be discarded. However, the concept of repositioning will need to be replaced by a "next" push at appropriate intervals.

Another awarding to the replace-ability of nonverbal advice might be to apply a animated conversational avatar with a range of nonverbal behaviors, including: mitt gestures, body posture shifts, gazing at and away from the patient, raising and lowering eyebrows, head nods, different facial expressions and variable proximity, which is described in greater item in Bickmore et al., [eighteen].

The benefits of using conversational avatars include: apply of verbal and nonverbal conversational behaviors that signify understanding and mark significance, and convey information in redundant channels of information (due east.chiliad., manus gestures, such as pointing, facial display of emotion, and eye gaze); apply of exact and nonverbal chatty behaviors to maximize comprehension; apply of verbal and nonverbal communicative behaviors used by providers to establish trust and rapport with their patients in social club to increase satisfaction and adherence to handling regimens; and accommodation of their messages to the item needs of patients and to the immediate context of the chat [18].

The location of the almost challenging concepts within the consent form are visually shown in ►Figure 2, indicating areas where boosted fabric should be made available at the request of the participant in the course of a Ofttimes Asked Question (FAQ) handout or additional on-need content. Similar to Bickmore et al., results in this study demonstrate that contiguous interaction allows researchers to dynamically appraise a participant'southward level of understanding based on the participant's verbal and nonverbal beliefs and to echo or elaborate information as necessary [18].

The benefits of using a FAQ for further clarifying information on the consent class is that it presents data in consistent manner in a low-pressure surround in which patients are free to have as much time as they demand to thoroughly sympathise information technology [18]. Although research coordinators encourage participants to ask questions, they oftentimes fail to elicit participant'south questions and participants with express wellness literacy are even less likely than others to ask questions [18].

Enquiry coordinators rarely, if ever, read the text of the consent grade verbatim. The fundamental finding of the content analysis is that researcher coordinator used both paraphrased and personalized communications and the level of paraphrasing vs. personalization is variable by transcript and by section of the consent form. The communication analysis suggests that data is tailored to the participant using non-legalistic conversational linguistic communication. Tailoring information to a particular research participant within a calculator-based grooming environment could be washed using a comprehension test every bit a function of the informed consent process similar to that used past Taub et al. through the report of the effect of vocabulary level and corrected feedback [vii].

There are several limitations to this study that affect the generalizability of the results. The study was conducted with a small convenience sample in a single lab setting where participants were not really enrolling in the report and were encouraged to inquire questions. The limitation of having subjects who weren't enrolling in the PMRP projection may have affected the number and types of questions participants asked, merely this is mitigated past the fact that all subjects were eligible to enroll in PMRP through the standard protocol.

Despite the photographic camera'southward being unobtrusively mounted in the ceiling, there is still a chance that functioning anxiety afflicted the nonverbal behaviors of the enquiry coordinator as they attempted to habituate to the setting. Future studies should balance the researcher'southward benefits of a naturalistic setting (e.one thousand., potentially meliorate quality interactions) against the enquiry subject field'due south protections in a "mock" lab setting (east.g., improve privacy and blinding of researchers). Having only 1 enquiry coordinator administer all of the consents presents a bias due to the small-scale sample size, and personal nature of nonverbal and verbal behaviors, nevertheless this may exist offset by their familiarity and expertise with administering the PMRP consent process that allows them to habituate to the setting better than someone who is less familiar with administering the consent, and to explain things in a more consistent way due to increased practice. Another limitation for the observational analysis was that inter-rater reliability was non formally calculated, as a second reviewer did observe a similar set of gestures for 2 transcripts simply at a coarser granularity than the showtime reviewer did. For the content analysis, simply four transcripts were used due to availability.

This study uses several unique methods of analysis to reinforce the importance of capturing the nonverbal and verbal communication of the informed consent procedure in a more consummate way than previous research studies demonstrate.

vi. Conclusion

In the consenting process, a large number and variety of non-verbal and exact communications supplemented the textual information. This study presents a systematic analysis of the nonverbal and verbal elements of an informed consent process, with the ultimate goal of developing a multimedia informed consent awarding. By extension, any multi-media informed consent process should take into account the nonverbal, verbal, and textual elements make up the consenting process equally experienced by the research discipline.

Clinical Relevance Statement

Effective patient-provider or participant-researcher communication and consumer education relies on the coordination of nonverbal, verbal, textual, and potentially multimedia advice. The application of our proof-of-concept results can be used to improve informed consent processes and consumer education materials to increment patient understanding and retentiveness.

Conflict of Interest

The authors take no conflicts to report. Joseph Plasek had full admission to all of the data in the study and takes responsibleness for the integrity of the information and the accuracy of the data analysis.

Man Subjects Review

The study was performed in compliance with the World Medical Clan Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects and was reviewed and approved by the Institutional Review Boards of Marshield Clinic and the University of Minnesota.

Acknowledgments

This study was grant funded by NIH National Human Genome Enquiry Establish as a part of the eMERGE project, grant number 5 U01 U01HG04608. The authors would like to give thanks Wendy Foth, the primary research coordinator for PMRP at the Marshfield Dispensary for participating in the written report. The authors would also like to thank the Marshfield Clinic staffs who were involved with the larger study objectives: Valerie D. McManus, Carol J. Waudby, Joe Ellefson, Dave G. Hoffman, Nancy Stueland-Adamski. The authors would also like to thank the four anonymous reviewers for their comments.

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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3631917/